AB0957 IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES AMONG PATIENTS WITH RESOLUTION OF ENTHESITIS AND/OR DACTYLITIS: POST HOC ANALYSES FROM THE KEEPSAKE 1 AND 2 TRIALS OF RISANKIZUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
Authors: S. Kwatra, S. Khattri, A. Amin, R. Liu, B. Padilla, A. M. Soliman, B. Kaplan, D. Mcgonagle
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Enthesitis and dactylitis are associated with greater disease activity and reduced quality of life. Results from the phase 3 randomized, placebo-controlled KEEPsAKE 1 and 2 studies (NCT03675308; NCT03671148) of risankizumab in active PsA showed greater resolution of enthesitis and dactylitis with risankizumab 150 mg vs placebo at week 24. <h3>Objectives</h3> This post hoc analysis evaluated improvements in patient-reported outcomes (PROs) among patients who had enthesitis (n=444), dactylitis (n=188), or both (n=128) at baseline and achieved resolution of enthesitis, dactylitis, or both with blinded risankizumab at weeks 0, 4, 16, and open-label risankizumab every 12 weeks thereafter. <h3>Methods</h3> Assessments included achievement of minimal clinically important differences (MCID) in pain (≥10-mm decrease on visual analog scale), Health Assessment Questionnaire-Disability Index (HAQ-DI; ≥0.35-unit decrease), and Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue; ≥4-point increase). Nonresponder imputation (with multiple imputation for COVID-19–related missing data at week 24) was used. <h3>Results</h3> Many patients who achieved resolution of enthesitis at week 24|week 52 also achieved MCID in pain (66.4%|71.4%), HAQ-DI (58.2%|63.4%), and FACIT-Fatigue (59.0%|72.1%). Many patients who achieved resolution of dactylitis at week 24|week 52 also achieved MCID in pain, (72.2%|81.7%), HAQ-DI (56.3%|66.2%), and FACIT-Fatigue (67.7%|69.9%). Many patients who achieved resolution of both enthesitis and dactylitis at week 24|week 52 also achieved MCID in pain (82.1%|86.4%) HAQ-DI (66.7%|69.2%), and FACIT-Fatigue (71.4%|74.6%). PRO results for patients for who did not achieve resolution of enthesitis and/or dactylitis will be presented. <h3>Conclusion</h3> Majority of patients who achieved resolution of enthesitis and/or dactylitis with risankizumab also reported improvements in pain, disability, and fatigue. <h3>Acknowledgements</h3> AbbVie and the authors thank the patients who participated in the study and all study investigators for their contributions. Medical writing assistance, funded by AbbVie, was provided by Lisa M Pitchford, PhD, of JB Ashtin. <h3>Disclosure of Interests</h3> Shawn Kwatra Consultant of: AbbVie, Aslan Pharmaceuticals, Arcutis, Celldex, Galderma, Genzada Pharmaceuticals, Incyte, Johnson &amp; Johnson, Novartis, Pfizer, Regeneron, and Sanofi., Grant/research support from: Galderma, Incyte, Pfizer, and Sanofi., Saakshi Khattri Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, and UCB, Grant/research support from: Bristol Myers Squibb, LEO Pharma, Novartis, and Pfizer, Ahmad Amin Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, LEO Pharma, Regeneron, Sanofi/Genzyme, Pfizer, and UCB, Ran Liu Shareholder of: AbbVie, Employee of: AbbVie, Byron Padilla Shareholder of: AbbVie, Employee of: AbbVie, Ahmed M. Soliman Shareholder of: AbbVie, Employee of: AbbVie, Blair Kaplan Shareholder of: AbbVie, Employee of: AbbVie, Dennis McGonagle Speakers bureau: AbbVie, Janssen, Novartis, and Pfizer., Grant/research support from: AbbVie, Janssen, Novartis, and Pfizer, UCB, BMS, Celgene.